FDA 483 - Nephron Sc Inc - August 22, 2025

Nephron SC Inc., a sterile drug manufacturing and 503B outsourcing facility located in West Columbia, SC, was inspected by the FDA from August 11 to August 22, 2025. The inspection revealed significant compliance issues related to aseptic processing and environmental monitoring, posing potential risks of microbiological contamination to sterile drug products.

Key violations identified include inadequate airflow visualization studies under dynamic conditions, poor aseptic practices, and insufficient control over aseptic operations. Specifically, the firm failed to perform adequate smoke studies to ensure unidirectional airflow in critical zones, did not enforce proper sanitization and personnel practices, and allowed environmental disruptions during aseptic operations. Additionally, the media fill program was found lacking in simulating worst-case conditions, and the disinfectant efficacy study did not demonstrate adequate decontamination capabilities.

The environmental monitoring program was also deemed insufficient, as it did not cover all critical surfaces and locations within classified areas, particularly those frequently contacted by operators. This oversight increases the risk of undetected microbial contamination.

The FDA requires Nephron SC Inc. to address these deficiencies by establishing robust procedures to prevent contamination, enhancing aseptic practices, and implementing a comprehensive environmental monitoring program. The firm must ensure that all corrective actions are scientifically sound and effectively maintain sterility assurance for their drug products. Failure to comply may result in further regulatory actions.